NCT00168077已完成3 期
Efficacy and Tolerance of BERIPLEX® P/N in Subjects With Acquired Deficiency of Coagulation Factors II, VII, IX and X Due to Oral Anticoagulation
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 40
- 试验地点
- 17
- 主要终点
- Rapid reversal of anticoagulatory effect
研究概览
简要总结
Patients on oral anticoagulants need rapid reversal of the anticoagulant effect in case of acute bleeding or emergency surgery. Prothrombin Complex Concentrates are known to provide a fast reversal of the anticoagulant effect, with several advantages over alternatives like vitamin K or FFP.The planned clinical Phase III study is designed to provide clinically relevant data on efficacy and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects on oral anticoagulation requiring rapid reversal due to acute bleeding or emergency surgery
- •INR > 2 at baseline
排除标准
- •Acute thromboembolic event
- •Treatment with any other investigational drug in the last 30 days before study entry
- •Less than 2 weeks of stable oral anticoagulation
结局指标
主要结局
Rapid reversal of anticoagulatory effect
次要结局
- Clinical efficacy assessment (hemostatic effect)
- Increase of coagulation factors
研究者
研究点 (17)
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Efficacy and tolerance of BERIPLEX® P/N in subjects with acquired deficiency of coagulation factors II, VII, IX and X due to oral anticoagulation - N/AAcquired deficiency of coagulation factors II, VII, IX and X due to oral anticoagulation requiring an immediate reversal of anticoagulant effect (i.e. emergency surgery or acute bleeding).MedDRA version: 7.1Level: LLTClassification code 10000534EUCTR2005-000382-19-LTZLB Behring GmbH40
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Efficacy and tolerance of BERIPLEX® P/N in subjects with acquired deficiency of coagulation factors II, VII, IX and X due to oral anticoagulation - N/AAcquired deficiency of coagulation factors II, VII, IX and X due to oral anticoagulation requiring an immediate reversal of anticoagulant effect (i.e. emergency surgery or acute bleeding).MedDRA version: 7.1Level: LLTClassification code 10000534EUCTR2005-000382-19-ATZLB Behring GmbH40
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Efficacy and tolerance of BERIPLEX® P/N in subjects with acquired deficiency of coagulation factors II, VII, IX and X due to oral anticoagulation - N/AAcquired deficiency of coagulation factors II, VII, IX and X due to oral anticoagulation requiring an immediate reversal of anticoagulant effect (i.e. emergency surgery or acute bleeding).MedDRA version: 7.1Level: LLTClassification code 10000534EUCTR2005-000382-19-DEZLB Behring GmbH40
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Efficacy and tolerance of BERIPLEX® P/N in subjects with acquired deficiency of coagulation factors II, VII, IX and X due to oral anticoagulation - N/AEUCTR2005-000382-19-HUZLB Behring GmbH40
已完成
3 期
Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant TherapyBlood Coagulation DisordersAcute Major BleedingNCT00708435CSL Behring216